Mylotarg 5mg price in india minimal at yourmedikart gemtuzumab ozogamicin for injection dose.
Mylotarg is a monoclonal antibody link to a chemotherapy drug. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
Mylotarg is used to treat a certain type of newly diagnose acute myeloid leukemia in adults and children at least 1 month old.
Mylotarg is also used to treat CD33-positive acute myeloid leukemia after other treatments did not work or have stopped working in adults and children at least 2 years old.
- Generic Name: Gemtuzumab Ozogamicin for injection
- Brand Name: Mylotarg
- Drug Class: Antineoplastics, Antibiotic
This medication is used to treat a certain type of leukemia (CD33-positive acute myeloid 5mg leukemia-AML). Mylotarg Price in India minimal at Yourmedikart. Mylotarg Gemtuzumab ozogamicin This medication works by slowing or stopping the growth of cancer cells.
How to use Mylotarg 5mg Vial
This medication is give by slow injection into a vein as direct by your doctor, usually over 2 hours. To mylotarg price decrease the risk of side effects, your doctor may give you other medications (such as acetaminophen, diphenhydramine) before your injection. The dosage and treatment schedule are based on your medical condition, response to treatment, and body size.
To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.
What is Mylotarg 5mg and how is it used?
- Mylotarg 5mg is a prescription medicine used to treat the symptoms of Acute Myeloid Leukemia. Mylotarg 5mg may be used alone or with other medications.
- Mylotarg 5mg belongs to a class of drugs called Antineoplastics, Antibiotic; Antineoplastics, Monoclonal Antibody. Mylotarg Price in India minimal at Yourmedikart
- It is not known if Mylotarg 5mg is safe and effective in children younger than 1 month of age.
CLINICAL PHARMACOLOGY
Mechanism Of Action
Gemtuzumab ozogamicin for injections a CD33-directed antibody-drug conjugate (ADC). The antibody portion (hP67.6) recognizes human CD33 antigen. The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker. Nonclinical data suggest that the anticancer activity of gemtuzumab ozogamicin for injection is due to the binding of the ADC to CD33-expressing tumor cells, followed by internalization of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker. Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Pharmacodynamics
Saturation of a high percentage of CD33 antigenic sites is presumed to require for maximum delivery of calicheamicin to leukemic mylotarg indication blast cells. Near maximal peripheral CD33 saturation was observed across studies after gemtuzumab ozogamicin for injection dosing at dose levels of 2 mg/m² and above.
At 9 mg/m² gemtuzumab ozogamicin (2 doses, 14 days apart), the risk for VOD increases as the Cmax of the first dose of gemtuzumab ozogamicin mylotarg price for injection increases. The increase in VOD is more prominent in patients with prior stem cell transplantation.
Pharmacokinetics
There are no clinical PK data for the fractionated regimen. When gemtuzumab ozogamicin is administer at 9 mg/m² (2 doses, 14 days apart), the Cmax following the first dose for patients who received 9 mg/m² gemtuzumab ozogamicin was 3.0 mg/L and increase to 3.6 mg/L after the second dose.
Distribution
N-acetyl gamma calicheamicin dimethyl hydrazide is approximately 97% bound to human plasma proteins in vitro. Population PK analyses gemtuzumab ozogamicin price found the total volume of distribution of hP67.6 antibody (sum of V1 [6.31 L] and V2 [15.1 L]) to be approximately 21.4 L in patients.
Elimination
The clearance (CL) value of hP67.6 from plasma was 0.35 L/h after the first dose and 0.15 L/h after the second dose, a decrease of roughly 60%. The terminal plasma half-life (t½) for hP67.6 was 62 hours after the first dose and 90 hours after the second dose.
Metabolism
In vitro studies demonstrate that N-acetyl gamma calicheamicin dimethyl hydrazide is extensively gemtuzumab ozogamicin for injection metabolized, primarily via no enzymatic reduction of the disulfide moiety.
Specific Populations
Age, race, sex, mild or moderate renal impairment (creatinine clearance [CLcr] 30-89 mL/min calculated by the Cockcroft-Gault equation) or mild hepatic impairment had no clinically significant effect on the pharmacokinetics of gemtuzumab ozogamicin. The pharmacokinetics of gemtuzumab ozogamicin in patients with severe renal impairment (CLcr 15-29 mL/min) or moderate (total bilirubin greater than 1.5x to 3.0x ULN) and severe hepatic impairment (total bilirubin greater than 3x ULN) is unknown.
Drug Interaction Studies
No clinical drug interaction studies have perform.
Side Effects
- Nausea, vomiting, constipation, or headache may occur. Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
- This medication may cause a serious infusion reaction. Similarly If this happens, Mylotarg gemtuzumab ozogamicin it is usually while the drug is give or within 24 hours of the dose. If you have chills, fever, trouble breathing, or severe dizziness, tell your doctor or pharmacist right away because your injection may need to stop.
- People using this medication may have serious side effects. However, you have mylotarg gemtuzumab ozogamicin prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
- This medication may lower your ability to fight infections. So, this may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn’t go away, fever, chills, cough).
Tell your doctor right away if you have any serious side effects, including easy bruising/bleeding.
- Get medical help right away if you have any very serious side effects, including fast/irregular heartbeat, severe dizziness, signs of bleeding (such as pink/bloody urine, dark/tarry stools, vomit that looks like coffee grounds), symptoms of bleeding in the brain (such as dizziness/fainting, sudden vision changes, nausea, seizures, confusion).
- A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
- This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
- In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
- In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345
Precautions
- Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
- Before using this medication, tell your doctor or pharmacist your medical history, especially of other blood/bone marrow disorders (such as increased white blood cell count), bone marrow transplant, liver disease, recent/current infection.
- This medication can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have expose to an infection or for more details.
- Tell your health care professional that you are using gemtuzumab ozogamicin before having any immunizations/vaccinations. Avoid contact with mylotarg injection with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
- To lower the chance of getting cut, bruise, or injure. Use caution with sharp objects like razors and nail cutters and avoid activities such as contact sports.
- It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding. While using this drug and for at least 1 month after stopping treatment is not recommend. Consult your doctor before breast-feeding.
Interactions
Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Lab and/or medical tests (such as complete blood count, liver function) should done while you are using this medication. Mylotarg Price in India minimal at Yourmedikart Keep all medical and lab appointments.
It is important to get each dose of this medication as scheduled. Mylotarg Price in India minimal at Yourmedikart. If you miss a dose, mylotarg 5 mg ask your doctor or Pharmacist right away for a new dosing schedule.
Not Applicable. This medication is give in a hospital or clinic and will not store at home.
Before taking this medicine
You should not be treat with Mylotarg if you are allergic to gemtuzumab ozogamicin.
To make sure Mylotarg is safe for you, tell your doctor if you have:
liver disease;
long QT syndrome (in you or a family member);
a stem cell transplant; or
an electrolyte imbalance (such as low levels of potassium or Magnesium in your blood).
Gemtuzumab ozogamicin can harm an unborn baby or cause birth defects if the mother or the father is using Mylotarg.
If you are a woman, mylotarg 5 mg you may need to have a negative Pregnancy test before starting this treatment. Use effective birth control to Prevent Pregnancy while you are using Mylotarg and for at least 6 months after your last dose.
If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
Tell your doctor right away if a Pregnancy occurs while either the mother or the father is using Mylotarg.
